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What Is Translation Reconciliation?

Translation reconciliation is a specialized quality assurance step used in life sciences translation to compare and harmonize two independently produced translations of the same source content. Unlike standard editing, which refines a single translation, reconciliation involves a side-by-side review by a third expert linguist to evaluate differences, resolve inconsistencies, and generate a single, regulator-ready final version.

Common Use Cases in Life Sciences:

  • Dual Forward Translation with Reconciliation:
    Often required in linguistic validation workflows for patient-reported outcomes (PROs), clinical outcome assessments (COAs), and ePROs to ensure conceptual equivalence and cultural relevance.
  • Independent Translation Reconciliation:
    Frequently applied to high-stakes clinical and regulatory documents such as protocols, investigator brochures (IBs), and informed consent forms (ICFs) to meet agency expectations across global markets.

Producing a single harmonized version through reconciliation helps ensure terminological consistency, preserves scientific intent, and reduces the risk of miscommunication in clinical trials, labeling, and regulatory submissions.

When and Why Reconciliation Is Required

Translation reconciliation is a critical step in clinical and regulatory translation workflows, required to meet the stringent expectations of global health authorities. Agencies such as the FDA, EMA, MHRA, and PMDA increasingly expect sponsors to demonstrate translation accuracy, consistency, and equivalence through formal reconciliation processes.

Reconciliation is an essential component of linguistic validation for clinical outcome assessments (COAs), including patient-reported outcomes (PROs), observer-reported outcomes (ObsROs), and electronic formats (ePROs and eCOAs). It ensures that dual forward translations are harmonized into a single version that retains conceptual accuracy and is culturally appropriate for the target population.

In clinical trial documentation, reconciliation is recommended or required for high-impact materials such as study protocols, informed consent forms (ICFs), investigator brochures (IBs), and clinical study reports (CSRs) to maintain regulatory compliance and patient safety across languages.

By resolving discrepancies early, reconciliation reduces the risk of submission delays, regulatory rejections, and misinterpretation of critical clinical content, protecting both data integrity and trial outcomes.

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Our Reconciliation Process

Sesen follows a structured, multi-step reconciliation process designed to meet the highest standards of linguistic accuracy, regulatory compliance, and clinical integrity. Each step is aligned with best practices in life sciences translation and supports seamless integration with sponsor and CRO workflows.

We begin with two independently produced translations of the same source document, each completed by qualified native linguists with subject matter expertise in the relevant therapeutic area. This dual translation approach forms the foundation for objective comparison and quality validation.

An experienced third-party linguist performs a comprehensive line-by-line comparison of the two versions to identify discrepancies, evaluate differences, and select the most accurate and clinically appropriate rendering.

  • All key terminology choices are reviewed for scientific accuracy and cultural relevance
  • Each change is fully justified in a reconciliation log, supporting transparency and regulatory audit readiness

If required, the reconciled draft is shared with the client or in-country reviewers for clarification or feedback. Our team manages query resolution promptly to ensure alignment with sponsor expectations and target population needs.

We conduct a final round of quality assurance to validate formatting, terminology consistency, numerical accuracy, and document completeness. This step ensures the reconciled version is linguistically sound and ready for downstream processes such as back translation or submission packaging.

Optional Add-on Services:

  • Back Translation for conceptual equivalence verification
  • Cognitive Debriefing Coordination for patient-facing content
  • Multilingual Formatting and DTP to support print and digital readiness

Sesen’s reconciliation workflows are fully compliant with ISO 17100 and ISO 9001:2015 and are tailored to the regulatory requirements of each project.

Expertise Across Life Sciences Translation

Sesen provides specialized translation reconciliation services across a broad spectrum of life sciences domains, supporting pharmaceutical, biotechnology, medical device, and CRO clients in achieving global compliance and patient safety. Our reconciliation workflows are tailored to the specific content type and regulatory context of each document to ensure clarity, consistency, and accuracy in every language.

We reconcile high-impact clinical trial materials such as informed consent forms (ICFs), investigator brochures (IBs), patient diaries, and clinical study reports (CSRs) to ensure alignment with protocol objectives and minimize the risk of miscommunication across global study sites.

Explore our Clinical Trial Translation Services

Our team supports reconciliation of regulatory content including Common Technical Documents (CTDs), summaries of product characteristics (SPCs), drug labeling, and written responses to health authorities. These reconciled documents meet the language accuracy and consistency standards required by agencies such as the FDA, EMA, and PMDA.

Learn more about Regulatory Submission Translation

Reconciliation is a critical component of dual forward translation workflows for patient-facing instruments such as patient-reported outcomes (PROs), clinical outcome assessments (COAs), and observer-reported outcomes (ObsROs). We ensure conceptual equivalence, clarity, and cultural appropriateness across all target languages.

Visit our Linguistic Validation Services

We apply reconciliation to Instructions for Use (IFUs), Directions for Use (DFUs), and usability questionnaires to meet MDR, IVDR, and FDA requirements. Our linguists are trained in medical device terminology and labeling conventions to ensure technical precision.

See our Medical Device Translation Services

Sesen reconciles screen-based content, metadata, and embedded text for electronic clinical outcome assessments and patient-reported outcome tools. This includes user interface strings, alerts, and validation questions to maintain functional and linguistic consistency in digital platforms.

Explore eCOA and ePRO Localization

Why Sesen

Sesen brings deep subject matter expertise and regulatory precision to every translation reconciliation project. Our approach is purpose-built for the life sciences industry, combining linguistic accuracy with operational transparency to support high-quality, audit-ready deliverables.

Every project is assigned to linguists who are native speakers of the target language and have direct experience in the relevant medical, pharmaceutical, or regulatory domain.

We operate under ISO 17100 and ISO 9001:2015 frameworks, ensuring rigorous quality control, documented processes, and continuous improvement in every phase of the reconciliation workflow.

Our reconciliation process is optimized for clinical trial documentation, regulatory submissions, and linguistic validation, with tailored review steps that align with agency expectations and therapeutic requirements.

All edits and terminology decisions are documented in structured reconciliation logs, providing full visibility for client teams and regulatory reviewers.

Final reconciled files are delivered in submission-ready formats with complete traceability, supporting compliance with FDA, EMA, PMDA, and other global authorities.

For projects that require high-volume or time-sensitive review, SesenGPT can be integrated to assist with terminology validation and consistency checks. This proprietary AI engine is trained exclusively on life sciences content and medical terminology.

Sesen combines expert human linguists, industry-standard processes, and intelligent technology to deliver translation reconciliation services that meet the most demanding regulatory and clinical standards.

Related Services

Looking for more than reconciliation? Explore our full range of life sciences language solutions:

Case Studies and Sample Deliverables

Sesen supports global life sciences organizations with large-scale, high-accuracy translation reconciliation projects tailored to clinical and regulatory requirements. Our team works behind the scenes on mission-critical documents that support global product approvals, patient safety, and trial integrity. Below are anonymized examples that demonstrate our capabilities:

  • Multinational Trial Support Across 22 Countries
    Reconciled over 2,000 patient-facing documents including PROs, ICFs, and diaries for a Phase III oncology trial involving 22 countries and 18 target languages. Final reconciled versions were delivered with full audit logs and terminology justification reports.
  • Accelerated Review Timelines for Regulatory Teams
    Reduced review time by 30 percent for bilingual reconciliation of regulatory submissions by implementing structured reconciliation logs, standardized change annotations, and early-stage discrepancy tracking.
  • Integrated QA for eCOA Deployment
    Delivered reconciled screen text and metadata for an eCOA instrument translated into 12 languages. Ensured consistency between UI strings and source COA using side-by-side logs and terminology validation with SesenGPT.
  • Labeling Reconciliation for EU MDR Compliance
    Provided harmonized translation reconciliation of 250+ IFUs and DFUs across 10 EU languages for a Class III medical device manufacturer to support MDR documentation updates and notified body submission.

Sesen can provide redacted samples of reconciliation logs and QA workflows upon request to help you evaluate our approach and compliance documentation standards.

Frequently Asked Questions (FAQs)

Reconciliation is a formal process that compares two independently translated versions of the same source text to resolve discrepancies and produce a single, unified version. It is typically performed by a third linguist who evaluates differences line by line and justifies each change.

Harmonization, while sometimes used interchangeably, more broadly refers to the act of aligning translated content across documents, languages, or versions to maintain consistency. In life sciences, harmonization may involve aligning multiple translated outputs to a master glossary or ensuring consistent phrasing across product families or related materials.
Reconciliation is a specific step within a project. Harmonization is often a project-wide objective.

Yes. Sesen frequently performs reconciliation on translations provided by clients, third-party vendors, or in-country reviewers. We can assess the linguistic quality, identify inconsistencies, and harmonize the versions using our structured reconciliation workflows. We also offer optional terminology alignment and style guide development to ensure future consistency.

We maintain consistency by using standardized glossaries, client-approved terminology, and domain-specific translation memories. During the reconciliation process, all key terms are reviewed and aligned across both versions. Optional integration with SesenGPT enables scalable terminology QA checks, especially in high-volume projects.

Yes. Every reconciliation project includes a detailed reconciliation log that documents changes, rationales, and terminology decisions. This ensures full transparency for client reviewers and satisfies the documentation expectations of regulatory authorities.

Reconciliation is recommended when accuracy, consistency, and regulatory compliance are critical. It is a required step in linguistic validation workflows and strongly advised for clinical trial documents, regulatory submissions, and patient-facing content. While not mandatory for every project, reconciliation significantly reduces risk in high-impact materials.

Start Your Reconciliation Project Today

Ready to ensure accuracy and consistency across your translated content? Upload your source and translated files for a free assessment. Our team will review the materials and provide a tailored quote along with recommended next steps.

A dedicated Sesen project manager will oversee your project from start to finish, ensuring regulatory alignment, linguistic accuracy, and on-time delivery.

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